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SESIÓN BIBLIOGRÁFICA HEMODINÁMICA Miércoles 11 de Marzo del 2015 Jeremías Bayón Lorenzo CvLPRIT: Complete versus Lesion only PRimary-PCI T rial

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Page 1: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

SESIÓN BIBLIOGRÁFICA HEMODINÁMICA

Miércoles 11 de Marzo del 2015Jeremías Bayón Lorenzo

CvLPRIT: Complete versus Lesion only PRimary-PCI Trial

Page 2: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

CvLPRIT: Complete versus Lesion only PRimary-PCI Trial

296 STEMI patients7 UK centers

146 infarct-only

150 complete revascularization

12 month follow-up

MACE: TOTAL MORTALITY, RECURRENT MI, HEART FAILURE AND

ISCHEMIA- DRIVEN REVASCULARIZATION

Page 3: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

CvLPRIT: Complete versus Lesion only PRimary-PCI Trial

Page 4: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

CvLPRIT: Complete versus Lesion only PRimary-PCI Trial

296 STEMI patients7 UK centers

146 infarct-only

150 complete revascularization

In the Complete Revascularization (CR) group, the infarct-related artery underwent PCI first before treatment of any significantly blocked non-infarct-related arteries, ideally within the same procedure but at least during the index hospitalization.

Page 5: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

CvLPRIT: Complete versus Lesion only PRimary-PCI Trial

296 STEMI patients7 UK centers

146 infarct-only

150 complete revascularization

• Randomization was stratified by infarct site (anterior vs nonanterior) and symptom-onset-to-balloon time (more or less than 3 hours).

• Significant blockage was defined as > 70% on single view or > 50% on 2 views. 

Page 6: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

CvLPRIT: Complete versus Lesion only PRimary-PCI Trial

296 STEMI patients7 UK centers

146 infarct-only

150 complete revascularization

• Complete revascularization increased both procedure time (55 vs 41 minutes; P < .0001) and contrast volume (250 vs 190 mL; P < .0001)

• Did not raise the risk of contrast-induced nephropathy (2% in each group; P = .95)

Page 7: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

  Infarct-Only

(n = 146)

Complete

(n = 150)

HR (95% CI) P Value

MACE 21.2% 10.0% 0.45

(0.24-0.84)

.009

All-Cause Mortality 4.1% 1.3% 0.32

(0.06-1.60)

.14

Recurrent MI 2.7% 1.3% 0.48

(0.09-2.62)

.39

Heart Failure 6.2% 2.7% 0.43

(0.13-1.39)

.14

Repeat Revascularization 8.2% 4.7% 0.55

(0.22-1.39)

.20

CvLPRIT: Complete versus Lesion only PRimary-PCI Trial

Page 8: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

CvLPRIT: Complete versus Lesion only PRimary-PCI Trial

1.- As a small study, it has low statistical power

2.- PRAMI and CvLPRIT together counted only 23 deaths.

Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Primary PCI for STEMI (COMPLETE)

To determine whether, on a background of optimal medical therapy, including ticagrelor, opening of all suitable narrowings or blockages found at the time of primary PCI for an acute heart attack is better than treating only the culprit lesion in patients with multi-vessel disease.

1. Primary Outcome Measures: Composite of Cardiovascular death or new myocardial Infarction 2.  Secondary Outcome Measures: Composite of CV death, new MI, ischemia-driven revascularization or hospitalization for unstable angina or heart failure  3. Other Outcome Measures: Major Bleeding

Estimated Enrollment: 3900

Study Start Date: December 2012

Estimated Study Completion Date: December 2018

Page 9: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

Bellemain-Appaix A, Kerneis M, O’Connor SA, et al. Reappraisal of thienopyridine pretreatment in patients with non-ST elevation acute coronary syndrome: a systematic review and meta-analysis. BMJ. 2014;Epub ahead of print.

- 7 studies, published between 2001 and 2013, including a total of 32,383 NSTE-ACS patients, of whom 17,545 (54.5%) underwent PCI.• 3 randomized controlled trials.• 1 observational analysis derived from a randomized trial• 3 observational studies

- Thienopyridine pretreatment varied. • Most studies involved a 300-mg clopidogrel loading dose, though 1

employed a loading dose of 600 mg and another left dosing to operator discretion.

• In the ACCOAST study, pretreated patients received a 30-mg dose of prasugrel at the time of diagnosis and another 30-mg dose with PCI. 

• No study was identified for ticagrelor or cangrelor, and analyses were thus limited to thienopyridines

Page 10: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

All cause death

Page 11: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

All cause death

Page 12: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

Major bleeding

Page 13: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

Major bleeding

Page 14: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

Page 15: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

Page 16: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

• No significant reduction of mortality (odds ratio 0-90 (0.75- to 1.07)

• A significant 30-45% excess of major bleeding was consistently observed in all patients (odds ratio 1.32 (1.16 to 1.49), P<0.0001) and in those undergoing PCI.

• There was a reduction in major adverse cardiovascular events in the analysis of all patients (odds ratio 0.84 (0.72 to 0.98), P=0.02), driven by the old clopidogrel studies (CURE and CREDO), but the difference was not significant for the cohort of patients undergoing PCI

• Stent thrombosis, stroke, and urgent revascularization did not differ between groups (pretreatment vs no pretreatment)

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

Page 17: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

Meta-analysis: No Need for Thienopyridine Loading Dose in NSTE-ACS Patients

1. In patients presenting with non-ST elevation ACS, pretreatment with thienopyridines is associated with no significant reduction of mortality but with a significant excess of major bleeding no matter the strategy adopted, invasive or not.

2. Our results do not support a strategy of routine pretreatment in patients with non-ST elevation ACS

Page 18: SESIÓN BIBLIOGRÁFICA HEMODINÁMICA › wp-content › uploads › 2014 › 11 › SESI… · 2.- PRAMI and CvLPRIT together counted only 23 deaths. Complete vs Culprit-only Revascularization

An interventional cardiologist without knwoledge is only just a posh plumber

GRACIAS